Simvastatin combined with Xarelto

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Wheezing Other Serious 11/2/2009 Male 12/14/2009 Physician Germany
Primary
Secondary
Concomitant
Wheezing Other Serious 11/2/2009 Male 12/18/2009 Physician Germany
Primary
Secondary
Concomitant
Wheezing Other Serious 11/2/2009 Male 3/17/2010 Physician Germany
Primary
Secondary
Concomitant
Wheezing Other Serious 11/2/2009 Male 3/22/2010 Physician Germany
Primary
Secondary
Concomitant
Wheezing Other Serious 11/2/2009 Male 3/30/2010 Physician Germany
Primary
Secondary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 12/11/2010 74 Male 176 lb 5/26/2011 Other Health Professional United Kingdom
Primary
Concomitant
Nausea Hospitalization 5/28/2011 74 Male 7/21/2011 Other Health Professional United Kingdom
Primary
Concomitant
C-reactive Protein Increased Hospitalization 2/18/2011 78 Male 154 lb 9/2/2011 Physician Germany
Primary
Concomitant
Asthenia Other Serious 10/15/2011 67 Female 11/7/2011 Other Health Professional United Kingdom
Primary
Concomitant
Chest Pain Hospitalization 10/28/2011 66 Male 187 lb 12/1/2011 Pharmacist United States
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 10/7/2011 76 Female 157 lb 12/7/2011 Other Health Professional Germany
Primary
Concomitant
Hallucination Other Serious 1/1/2011 83 Male 12/14/2011 Physician United States
Primary
Concomitant
Oesophagitis Hospitalization 9/26/2011 81 Male 183 lb 12/16/2011 Physician United States
Primary
Concomitant
Haemoglobin Decreased Other Serious Female 214 lb 12/19/2011 Pharmacist United States
Primary
Concomitant
Post Procedural Haematoma Hospitalization 11/21/2011 70 Male 159 lb 12/19/2011 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Dizziness Hospitalization 11/18/2011 84 Male 170 lb 12/23/2011 Other Health Professional United Kingdom
Primary
Concomitant
Deep Vein Thrombosis Other Serious 11/23/2011 76 Female 1/11/2012 Other Health Professional France
Primary
Concomitant
Venous Thrombosis Other Serious 10/17/2011 84 Female 1/11/2012 Other Health Professional France
Primary
Concomitant
Swollen Tongue Other Serious 12/1/2011 76 Female 124 lb 1/27/2012 Consumer United States
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 12/6/2011 70 Female 217 lb 1/30/2012 Pharmacist United States
Primary
Concomitant
Oesophagitis Hospitalization 9/26/2011 81 Male 183 lb 1/30/2012 Physician United States
Primary
Concomitant
Incorrect Route Of Drug Administration Hospitalization 1/1/2012 88 Male 185 lb 2/3/2012 Consumer United States
Primary
Concomitant
Hallucination 11/1/2011 84 Male 176 lb 2/23/2012 Physician United States
Primary
Concomitant
Venous Thrombosis Limb Life Threatening 12/22/2011 84 Female 2/24/2012 Other Health Professional France
Primary
Concomitant
Hallucination Other Serious 1/1/2011 69 Male 207 lb 2/24/2012 Pharmacist United Kingdom
Primary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 2/13/2012 54 Female 165 lb 2/28/2012 Physician Germany
Primary
Concomitant
Cerebrovascular Accident Life Threatening 2/17/2012 82 Male 214 lb 3/5/2012 Physician Germany
Primary
Secondary
Concomitant
Cerebrovascular Accident Life Threatening 2/17/2012 82 Male 214 lb 3/12/2012 Physician Germany
Primary
Secondary
Concomitant
Local Swelling Other Serious 2/1/2012 67 Female 3/14/2012 Consumer United States
Primary
Concomitant
Aphasia Other Serious 2/20/2012 74 Female 165 lb 3/15/2012 Physician Germany
Primary
Concomitant
Hallucination Other Serious 1/1/2011 69 Male 207 lb 3/16/2012 Pharmacist United Kingdom
Primary
Concomitant
Jaundice Hospitalization 2/1/2012 88 Male 3/16/2012 Other Health Professional United Kingdom
Primary
Concomitant
Local Swelling Other Serious 2/1/2012 67 Female 3/15/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Asthenia Other Serious 12/1/2011 76 Female 124 lb 3/20/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebral Haemorrhage Hospitalization 2/17/2012 82 Male 214 lb 3/20/2012 Physician Germany
Primary
Concomitant
Interacting
Abdominal Pain Other Serious 3/12/2012 82 Female 198 lb 3/23/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 3/12/2012 82 Female 198 lb 3/23/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Mouth Haemorrhage Other Serious 2/17/2012 82 Male 214 lb 3/26/2012 Physician Germany
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 2/22/2012 88 Male 183 lb 3/27/2012 Physician United States
Primary
Concomitant
Blood Urine Present Other Serious 3/20/2012 71 Male 200 lb 3/30/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Abdominal Pain Other Serious 3/12/2012 82 Female 198 lb 3/23/2012 Consumer United States
Primary
Secondary
Concomitant
Headache Other Serious 12/1/2011 76 Female 123 lb 4/2/2012 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 3/22/2012 59 Male 4/2/2012 Other Health Professional United States
Primary
Concomitant
Myocardial Infarction Hospitalization 66 Female 4/3/2012 Other Health Professional United States
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 3/12/2012 74 Female 4/3/2012 Physician Denmark
Primary
Concomitant
Blood Urine Present Other Serious 3/20/2012 71 Male 200 lb 3/30/2012 United States
Primary
Secondary
Concomitant
Haemoglobin Decreased Hospitalization 2/14/2012 78 Female 132 lb 4/5/2012 Physician Germany
Primary
Concomitant
Haemorrhagic Stroke Other Serious 2/14/2012 61 Female 217 lb 4/11/2012 Other Health Professional United States
Primary
Concomitant
Subarachnoid Haemorrhage Hospitalization 2/22/2012 88 Male 183 lb 4/12/2012 Physician United States
Primary
Concomitant
Platelet Count Decreased Hospitalization Female 171 lb 4/16/2012 Physician United States
Primary
Concomitant
Blood Uric Acid Increased Other Serious 2/1/2012 89 Male 175 lb 4/19/2012 Consumer United States
Primary
Concomitant
Atrial Fibrillation Death Female 171 lb 4/23/2012 Physician United States
Primary
Concomitant
Myocardial Infarction Hospitalization Female 194 lb 4/24/2012 Other Health Professional United States
Primary
Concomitant
Atrial Fibrillation Death Female 171 lb 4/27/2012 Physician United States
Primary
Concomitant
Laryngitis Other Serious 2/1/2012 76 Female 170 lb 4/30/2012 Other Health Professional United States
Primary
Concomitant
Post Procedural Haemorrhage Hospitalization 4/8/2012 83 Female 150 lb 5/2/2012 Physician United States
Primary
Concomitant
Dizziness Other Serious 12/1/2011 76 Female 123 lb 5/2/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Nausea Hospitalization 4/1/2012 79 Male 5/3/2012 Other Health Professional United States
Primary
Concomitant
Haemoglobin Decreased Hospitalization 2/14/2012 78 Female 132 lb 5/4/2012 Physician Germany
Primary
Concomitant
Splenic Rupture Hospitalization 4/1/2012 79 Male 5/7/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Nausea Hospitalization Female 148 lb 5/8/2012 Physician Germany
Primary
Concomitant
Liver Function Test Abnormal Life Threatening 2/14/2012 89 Female 148 lb 5/10/2012 Physician Germany
Primary
Concomitant
Cataract Operation Hospitalization 4/1/2012 79 Male 190 lb 5/10/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Death Other Serious 12/26/2011 84 Female 265 lb 5/11/2012 Physician Germany
Primary
Concomitant
Sudden Death Death 5/3/2012 75 Female 5/16/2012 Physician Belgium
Primary
Concomitant
Haemoglobin Decreased Hospitalization 2/14/2012 78 Female 132 lb 5/17/2012 Physician Germany
Primary
Concomitant
Anaemia Death 1/1/2012 83 Female 5/18/2012 Physician Germany
Primary
Concomitant
Headache Hospitalization 12/26/2011 84 Female 265 lb 5/18/2012 Physician Germany
Primary
Concomitant
Blood Alkaline Phosphatase Normal Hospitalization 2/14/2012 89 Female 148 lb 5/18/2012 Physician Germany
Primary
Concomitant
Aphthous Stomatitis Other Serious 4/1/2012 82 Male 194 lb 5/18/2012 Consumer United States
Primary
Concomitant
Swollen Tongue Other Serious 12/1/2011 76 Female 123 lb 5/23/2012 Physician United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 3/12/2012 47 Male 5/23/2012 Physician Germany
Primary
Concomitant
Anaemia Macrocytic Hospitalization 2/14/2012 78 Female 143 lb 5/24/2012 Physician Germany
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/1/2012 89 Female 148 lb 5/29/2012 Physician Germany
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 11/10/2011 74 Male 231 lb 6/4/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Epistaxis 5/10/2012 74 Male 161 lb 6/5/2012 Consumer United States
Primary
Concomitant
Gastrointestinal Haemorrhage Other Serious 11/10/2011 74 Male 231 lb 6/6/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Malaise Hospitalization 5/25/2012 61 Male 265 lb 6/6/2012 Consumer United States
Primary
Secondary
Concomitant
Rash Generalised Hospitalization 4/10/2012 Female 6/8/2012 Physician United States
Primary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 4/2/2012 88 Male 161 lb 6/8/2012 Physician Germany
Primary
Concomitant
Penile Haemorrhage Hospitalization 5/25/2012 61 Male 265 lb 6/14/2012 Consumer United States
Primary
Secondary
Concomitant
Faecal Incontinence Other Serious 4/1/2012 66 Female 202 lb 6/18/2012 Consumer United States
Primary
Concomitant
Gastrointestinal Haemorrhage Other Serious 11/12/2011 73 Male 231 lb 6/20/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Blister Hospitalization 5/24/2012 64 Female 177 lb 6/22/2012 Other Health Professional United States
Primary
Concomitant
Haemoglobin Decreased Other Serious 3/16/2012 81 Male 6/25/2012 Physician Germany
Primary
Secondary
Concomitant
Dysarthria Hospitalization 11/12/2011 73 Male 231 lb 6/20/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Arrhythmia Supraventricular Life Threatening 4/4/2012 91 Female 122 lb 7/2/2012 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Death 3/9/2012 86 Male 187 lb 7/2/2012 Physician United States
Primary
Concomitant
Cataract Operation Hospitalization 4/1/2012 79 Male 167 lb 7/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Cataract Operation Disability 4/1/2012 79 Male 167 lb 7/9/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Generalised Oedema 4/10/2012 74 Female 143 lb 7/12/2012 Physician Germany
Primary
Concomitant
Haemoglobin Decreased Other Serious 3/16/2012 81 Male 7/12/2012 Physician Germany
Primary
Secondary
Concomitant
Haemorrhage Intracranial Hospitalization 6/29/2012 68 Male 127 lb 7/17/2012 Physician United States
Primary
Concomitant
Inappropriate Schedule Of Drug Administration Other Serious 7/11/2012 67 Male 275 lb 7/20/2012 Consumer United States
Primary
Concomitant
Interacting
Drug Dose Omission Other Serious 5/1/2012 62 Female 232 lb 7/20/2012 Consumer United States
Primary
Concomitant
Drug Prescribing Error Hospitalization 6/1/2012 79 Male 195 lb 7/31/2012 Physician United States
Primary
Concomitant
Gastrointestinal Mucosal Disorder Hospitalization 3/16/2012 81 Male 7/31/2012 Physician Germany
Primary
Secondary
Concomitant
Haemorrhage Intracranial Hospitalization 7/20/2012 73 Male 187 lb 8/2/2012 Physician Germany
Primary
Concomitant
Interacting
Hepatitis Hospitalization 7/2/2012 64 Male 176 lb 8/3/2012 Other Health Professional Austria
Primary
Concomitant
Post Procedural Haemorrhage Other Serious 6/26/2012 88 Male 194 lb 8/3/2012 Physician Germany
Primary
Concomitant
Haemorrhage Intracranial Hospitalization 7/20/2012 73 Male 187 lb 8/7/2012 Physician Germany
Primary
Interacting
Seroma 5/1/2012 62 Female 232 lb 8/8/2012 Consumer United States
Primary
Concomitant
Shock Haemorrhagic Death 3/5/2012 73 Female 132 lb 8/9/2012 Physician Germany
Primary
Concomitant
Intestinal Ischaemia Other Serious 5/30/2012 49 Female 245 lb 8/10/2012 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Embolism Life Threatening 12/21/2011 74 Female 139 lb 8/10/2012 Other Health Professional United Kingdom
Primary
Concomitant
Drug Dose Omission 5/28/2012 63 Female 232 lb 8/14/2012 Physician United States
Primary
Concomitant
Lip Swelling Other Serious 1/1/2012 Male 8/17/2012 Pharmacist United States
Primary
Concomitant
Mesenteric Artery Thrombosis Other Serious 5/30/2012 49 Female 245 lb 8/20/2012 Physician Germany
Primary
Secondary
Concomitant
Intracardiac Thrombus Other Serious 5/14/2012 67 Male 187 lb 8/22/2012 Physician United States
Primary
Concomitant
Ischaemic Stroke Hospitalization 6/3/2012 72 Female 150 lb 8/22/2012 Physician Germany
Primary
Concomitant
Iron Deficiency Anaemia Other Serious 7/13/2012 75 Female 8/22/2012 Consumer Belgium
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 6/19/2012 62 Female 165 lb 8/27/2012 Physician Germany
Primary
Concomitant
Lung Disorder Disability 4/26/2012 82 Female 141 lb 11/19/2012 Physician Us
Primary
Concomitant
Weight Decreased Hospitalization 4/2012 Male 11/21/2012 Other Health Professional De
Primary
Concomitant
Embolic Stroke Hospitalization 5/29/2012 82 Male 132 lb 8/30/2012 Physician De
Primary
Concomitant
Iron Deficiency Anaemia Other Serious 7/13/2012 75 Female 9/19/2012 Consumer Be
Primary
Secondary
Concomitant
Basal Ganglia Haemorrhage Death 7/20/2012 73 Male 121 lb 11/26/2012 Physician De
Primary
Secondary
Concomitant
Interacting
Hypertension Death 8/13/2012 78 Male 195 lb 11/14/2012 Pharmacist Us
Primary
Concomitant
Nausea Other Serious 5/27/2012 71 Female 172 lb 8/30/2012 Physician De
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 6/29/2012 89 Female 12/6/2012 Physician De
Primary
Secondary
Wound Haemorrhage Other Serious 7/6/2012 78 Male 231 lb 9/7/2012 Physician De
Primary
Concomitant
Vomiting Other Serious 8/17/2012 76 Male 1/17/2013 Physician De
Primary
Secondary
Concomitant
Sensorimotor Disorder Other Serious 9/3/2012 86 Male 161 lb 9/18/2012 Physician De
Primary
Concomitant
Vomiting Disability 8/17/2012 76 Male 11/7/2012 Physician De
Primary
Secondary
Concomitant
Ventricular Septal Defect Other Serious 9/20/2012 Physician De
Primary
Secondary
Concomitant
Syncope Other Serious 8/10/2012 66 Male 9/20/2012 Physician Ch
Primary
Secondary
Concomitant
Gastrooesophageal Reflux Disease 8/2011 Female 165 lb 9/24/2012 Consumer Us
Primary
Concomitant
Urinary Bladder Haemorrhage Other Serious 8/19/2012 75 Male 194 lb 9/25/2012 Consumer De
Primary
Secondary
Concomitant
Interacting
Pulmonary Embolism Other Serious 7/23/2012 90 Male 12/14/2012 Physician Us
Primary
Concomitant
Syncope Hospitalization 8/10/2012 Male 9/27/2012 Consumer Ch
Primary
Secondary
Concomitant
Heart Rate Increased Other Serious 10/2/2012 68 Female 270 lb 10/10/2012 Consumer Us
Primary
Concomitant
Pulmonary Embolism Death 2012 Female 174 lb 11/5/2012 Physician Us
Primary
Concomitant
Pain In Extremity Other Serious 9/19/2012 61 Female 243 lb 10/11/2012 Other Health Professional Gb
Primary
Concomitant
Procedural Site Reaction Hospitalization 2012 67 Female 10/19/2012 Physician Br
Primary
Concomitant
Interacting
Urinary Tract Infection Other Serious Male 154 lb 12/6/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Diarrhoea Disability 8/30/2012 77 Male 10/26/2012 Physician Gb
Primary
Concomitant
Pulmonary Embolism Hospitalization 8/5/2012 78 Female 208 lb 11/14/2012 Pharmacist Us
Primary
Concomitant
Procedural Site Reaction Other Serious 2012 67 Female 11/5/2012 Physician Br
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 2012 Male 180 lb 11/1/2012 Consumer Us
Primary
Concomitant
Haemoglobin Abnormal Hospitalization 2012 Male 171 lb 12/17/2012 Physician Us
Primary
Concomitant
Haemorrhage Hospitalization 3/28/2012 78 Male 11/5/2012 Physician Us
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 9/26/2012 70 Female 11/15/2012 Physician Us
Primary
Concomitant
Ulcer Haemorrhage Hospitalization 6/12/2012 76 Male 150 lb 11/9/2012 Consumer Us
Primary
Concomitant
Hypotension Disability 3/10/2012 79 Female 187 lb 11/9/2012 Other Health Professional Gb
Primary
Concomitant
Hallucination, Visual Other Serious 10/12/2012 76 Female 267 lb 11/12/2012 Physician Gb
Primary
Concomitant
Micturition Urgency Other Serious 72 Male 11/8/2012 Consumer De
Primary
Concomitant
Incision Site Haemorrhage Other Serious 6/28/2012 72 Male 168 lb 11/19/2012 Physician De
Primary
Concomitant
Interacting
Wound Haemorrhage Disability 3/24/2012 80 Female 132 lb 11/13/2012 Other Health Professional Gb
Primary
Concomitant
Malaise Other Serious 10/24/2012 79 Male 185 lb 11/26/2012 Pharmacist Gb
Primary
Concomitant
Drug Ineffective Life Threatening 11/11/2012 68 Male 154 lb 11/29/2012 Physician De
Primary
Concomitant

Drug Data